S-MONOVETTE EDTA K2-GEL

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

IMMUSTRIP(TM) DSDNA ELISA TEST SYSTEM

FDA 510(k)

FDA Class 2 ·Immunology

BINDAZYME ANTI-DSDNA EIA KIT

FDA 510(k)

FDA Class 2 ·Immunology

3M ANTI-DSDNA FAST TEST

FDA 510(k)

FDA Class 2 ·Immunology

IS-DSDNA TEST SYSTEM

FDA 510(k)

FDA Class 2 ·Immunology

DSDNA IMMUNOGLOBULIN EIA TEST SYSTEM

FDA 510(k)

FDA Class 2 ·Immunology

NDNA ANTIBODY TEST KIT

FDA 510(k)

FDA Class 2 ·Immunology

VARELISA COMBINED DNA ANTIBODIES EIA

FDA 510(k)

FDA Class 2 ·Immunology

VARELISA DSDNA ANTIBODIES (FARR VERSION)

FDA 510(k)

FDA Class 2 ·Immunology

AUTOSTATTMII ANTI-DSDNA

FDA 510(k)

FDA Class 2 ·Immunology

MDI DS-DNA TEST

FDA 510(k)

FDA Class 2 ·Immunology

VARELISA SSDNA ANTIBODIES, MODEL 14896

FDA 510(k)

FDA Class 2 ·Immunology

SERAQUEST ANTI-DSDNA

FDA 510(k)

FDA Class 2 ·Immunology

Straumann BLX Ø3.5 mm Implants

FDA 510(k)

FDA Class 2 ·Dental

STABLYX CMC ARTHROPLASTY IMPLANT MODEL SIZES 1, 2, 3, 4, AND 5

FDA 510(k)

FDA Class 2 ·Orthopedic

SANPOINT MENSTRUAL TAMPON

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Molecular Transport Media - MTM

FDA 510(k)

FDA Class 2 ·Microbiology

Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·COBAS AMPLIPREP/COBAS TAQMAN HCV TEST

Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ROCHE MOLECULAR SYSTEMS COBAS AMPLIPREP/COBAS AMPLICOR HCV TEST

Cytomegalovirus (Cmv) Dna Quantitative Assay

FDA Pre-Market Approval

FDA Class 2 ·ARTUS CMV RGQ MDX KIT